Status:
UNKNOWN
GI Symptoms and Sleep Disturbances in Patients With Quiescent Crohns Disease
Lead Sponsor:
University of Aarhus
Conditions:
Crohn's Disease
Inflammatory Bowel Disease
Eligibility:
All Genders
18-85 years
Brief Summary
In this study we would like to clarify the effect of long lasting Crohn's Disease on motility of the gastrointestinal system in patient and the effect regarding sleep disturbances. This will be done w...
Eligibility Criteria
Inclusion
- Patients with CD based on accepted endoscopic and histological criteria (according to ECCO guidelines (17) )
- Age ≥18 years
- A minimum disease duration of five years
- Remission defined by Faecal calprotectin \< 100 and CRP level within normal values for a minimum of 1 month
- Baseline values:
- CRP normal
- Faecal calprotectin \< 100
- Ileocoecal and/or colic localization of disease (Montreal phenotype classification)
- One or more IBS-like-symptoms (abdominal pain and discomfort, diarrhea, constipation)
Exclusion
- Stricturizing CD
- Obvious stenotic symptoms
- Previous major gastrointestinal surgery
- Diagnosis of other gastrointestinal diseases affecting motility (ex. Coeliac disease)
- Medication altering gastrointestinal motility
- Hepatobiliary disease (PSC)
- Diabetes Mellitus
- Metabolic disorder
- Bacterial overgrowth (hydrogen breath test)
- Planned MR scan in the four weeks following capsule intake (safety precaution)
- Abdominal diameter \> 140 cm
- Implanted electronic devices (pacemaker, ICD, etc.)
- Diagnosed sleep disorder
- Pregnancy and breast feeding
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02245594
Start Date
October 1 2014
End Date
October 1 2015
Last Update
September 19 2014
Active Locations (1)
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1
Aarhus University Hospital, Department of Gastroenterology and Hepatology
Aarhus C, Denmark, 8000